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WO2000045737A1 - Prothese endovasculaire tubulaire uretrale, biliaire, ou oesophagienne - Google Patents

Prothese endovasculaire tubulaire uretrale, biliaire, ou oesophagienne Download PDF

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Publication number
WO2000045737A1
WO2000045737A1 PCT/IT2000/000032 IT0000032W WO0045737A1 WO 2000045737 A1 WO2000045737 A1 WO 2000045737A1 IT 0000032 W IT0000032 W IT 0000032W WO 0045737 A1 WO0045737 A1 WO 0045737A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubular
endoprosthesis according
endoprosthesis
net
tube
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IT2000/000032
Other languages
English (en)
Inventor
Pietro Quaretti
Bruno Rovereto
Marco Pasquinucci
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to EP00905261A priority Critical patent/EP1158932A1/fr
Priority to AU26884/00A priority patent/AU2688400A/en
Publication of WO2000045737A1 publication Critical patent/WO2000045737A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the present invention relates to a tubular endoprosthesis, commonly known with the English name stent, and particularly to an endoprosthesis which can be used for treating stenosis or an occlusion of urethral ducts or other non- sanguineous structures, for example those of the biliary ducts or of the esophagus.
  • the present invention relates to the use of said endoprosthesis.
  • the ureter is known to be a muscle-membranous duct, provided with its own peristalsis and internally covered with a particular epithelium, called urothelium, which has the function of conveying to the bladder the urine excreted by the kidney.
  • the stenosis or the total occlusion of the ureter leads to occlusive nephropathy which brings to a loss of the renal function if it is not treated in time.
  • the occlusion is bilateral, i.e. it occurs at both ureters, a renal failure, which is incompatible with the patient survival, takes place if no operation for substituting the renal function is effected, for instance extra-corporeal dialysis or a kidney transplantation.
  • the cause of the ureter occlusion is determined by advanced neoplastic processes, such as relapses of tumors of the colon or rectum, of the prostate or of the bladder, gynecologic tumors (uterus or ovaries), or periaortic lymphadenopathies, i.e. it is due to clinic situations wherein the basic disease cannot be radically treated anymore, the patient cannot obviously undergo a transplantation and is universally excluded from any program of extra-corporeal dialysis.
  • advanced neoplastic processes such as relapses of tumors of the colon or rectum, of the prostate or of the bladder, gynecologic tumors (uterus or ovaries), or periaortic lymphadenopathies, i.e. it is due to clinic situations wherein the basic disease cannot be radically treated anymore, the patient cannot obviously undergo a transplantation and is universally excluded from any program of extra-corporeal dialysis.
  • the solution of the occlusive problem can improve the life quality of the patient and/or lengthen his survival, so that a few so-called endourologic procedures are practiced, which allow the occlusive problem to be solved with a palliative and without surgical access (open surgery).
  • the urologist positions a plastic pipe, for instance made with polyurethane or silicone and generally known with the English name plastic stent, through the urethral occlusion by techniques which are derived from the intervention radiology.
  • tubular endoprosthesis commonly known with the English name metal stent, which comprise a tubular metal net made with stainless steel or nitinol, a particular elastic nickel-titanium alloy.
  • metal stent which comprise a tubular metal net made with stainless steel or nitinol, a particular elastic nickel-titanium alloy.
  • These prostheses which are self-expansible or expansible by means of a ball catheter, have been found to be useful in the treatment of stenosis and occlusions.
  • the advantage of this kind of prosthesis consist in their considerable compressibility in the insertion into an even small access hole, thereby obtaining in any case through the stenosis an end lumen which is greater than that obtainable by plastic endoprosthesis.
  • the endoprosthesis metal net is passed through by the hyperplastic reaction of the urothelium that actively proliferates in response to the extension.
  • the urothelium response can often be excessive, thus determining the endoprosthesis occlusion. From published researches, only the 67% of 95 ureters provided with this endoprosthesis have been found to be accessible for a significant period of time.
  • the endoprosthesis occlusion can also occur by proliferation through the metal net meshes of tumor tissue or inflammatory granulation tissue or by extension of the tumor to the ureter segments which are not provided with the endoprosthesis.
  • the reaction of the urothelium through the endoprosthesis is considered to be a positive phenomenon because at the end it is incorporated and fixed to the urothelium, without deposit and migration risks.
  • a third kind of tubular endoprostheses is known, commonly called with the English name stent-graft, wherein the metal net is still self-expansible or expansible with a ball, and is externally or sometimes internally covered by a biocompatible fabric, for instance one made with polyester or polyurethane.
  • the stent-grafts born for applications in blood vessel, for example for the treatment of aneurysms or arterovenous fistulae, have never been used in the urethral ducts, although the covering of the tubular metal net with the biocompatible fabric is capable of impeding the passage of the urothelium, of the tumor tissue or of the granulation tissue through said net, thus providing for a remedy for the drawbacks of the purely metal endoprosthesis.
  • Object of the present invention is therefore to provide an endoprosthesis which is free from said drawbacks, that is an endoprosthesis which remains easily in its position and which cannot be obstructed.
  • the endoprosthesis whose main features are specified in the first claim and other features are specified in the following claims. Thanks to the loops which it is provided with, the endoprosthesis according to the present invention remains stably positioned, because the internal walls of the duct wherein it is placed are capable of anchoring themselves stably by going through and incorporating said loops, thus avoiding possible migrations which may damage the patient. Further, said loops are obtained by suitably bending some portions of the tubular net meshes, with following advantageous economicity in the manufacture and simplicity in use.
  • Another advantage of the endoprosthesis according to the present invention consists in the particular shapes that the meshes of the tubular net can take depending on the kind of required application, by obtaining anyway a plurality of loops for the fastening to the internal walls of the patient's ducts.
  • a further advantage of the endoprosthesis according to the present invention is that, according to the physical features of the metallic material which the tubular net is made with, the shape and the arrangement of the loops are permanently and perfectly correct even after the endoprosthesis compression, which is necessary for the installation thereof.
  • FIG. 1 shows a front view of a first embodiment of the endoprosthesis according to the present invention
  • figure 2 shows a partial side view of the endoprosthesis of figure 1;
  • figure 3 shows a partial view of the metal wire used for the tubular net of the endoprosthesis of figure 1 ;
  • FIG. 4 shows a front view of a second embodiment of the endoprosthesis according to the present invention
  • figure 5 shows a partial side view of the endoprosthesis of figure 4;
  • FIG. 6 shows a front view of a third embodiment of the endoprosthesis according to the present invention.
  • - figure 7 shows a partial side view of the endoprosthesis of figure 6
  • - figure 8 shows a front view of a fourth embodiment of the endoprosthesis according to the present invention:
  • - figure 9 shows a partial side view of the endoprosthesis of figure 8;
  • FIG. 10 shows a front view of a fifth embodiment of the endoprosthesis according to the present invention.
  • - figure 11 shows a partial side view of the endoprosthesis of figure 10
  • - figure 12 shows a partial view of the metal wire used for the tubular net of the endoprosthesis of figure 10;
  • FIG. 13 shows a front view of a sixth embodiment of the endoprosthesis according to the present invention.
  • - figure 14 shows a partial side view of the endoprosthesis of figure 13
  • - figure 15 shows a partial view of the metal wire used for the tubular net of the endoprosthesis of figure 13;
  • figure 16 shows a partial side view of the endoprosthesis of figure 1 , in the condition of compression into a tubular container.
  • the first embodiment of the endoprosthesis according to the present invention comprises in a known way at least one cylindrical tube 1 made with a biocompatible fabric, particularly with a fabric in a synthetic material having low porosity, having a diameter, in the extended condition, comprised between 5 and 10 mm.
  • a tubular net 2 is fastened, having substantially the same diameter, which is preferably made with a nickel-titanium alloy known with the name nitinol.
  • this particular alloy is characterized by high elasticity as well as by the so-called “shape-memory” which enables the structure made with this alloy to take again a predetermined shape depending on the temperature whereat said structure was manufactured, for instance 37° C, corresponding to human body temperature.
  • tubular net 1 In order to favor adhesion to the internal walls of the duct wherein the endoprosthesis is inserted, some portions of the meshes of tubular net 2 are suitably bent outwards, so that they form a multiplicity of loops 3 wherein the epithelium of said duct, particularly the ureter epithelium, can get inserted.
  • loops 3 preferably protrude of at least 1 mm out of fabric tube 1.
  • tubular net 1 can be seen to be preferably obtained by zigzag bending a single metal wire so as to form a substantially triangular wave having alternated crests and valleys of two different heights.
  • the upper and lower profile of said triangular wave are provided with a whole periodical height increase, for instance every 24 crests, so that said wire can be easily winded around fabric tube 1 by following a helicoidal profile, so that tubular net 2 is obtained.
  • crests 4 and valleys 5 which are arranged along the external profiles of the triangular wave are joined, for instance by microscopic sutures, to valleys 6 and crests 7 respectively of the adjacent portions included in a wave period, as well as possibly fastened to fabric tube 1 , again with said sutures.
  • the points of crests 8 and valleys 9 included between the external wave profiles are bent outwards, so that a multiplicity of loops 3 having triangular shape is formed when the metal wire is winded around fabric tube 1.
  • the second embodiment of the endoprosthesis according to the present invention comprises again one tubular net 2 fastened outside one fabric tube 1.
  • tubular net 2 is preferably made with a single metal wire which is zigzag bent so as to form a substantially triangular wave, which is though provided with the crests and the valleys arranged only along the lower profile and the upper profile of the wave.
  • loops 3 are obtained by bending outwards only the points of the crests of a portion comprised in a wave period and the corresponding points of the valleys of the adjacent wave portion, which are reciprocally fixed, again with microscopical sutures, at a certain distance from the fabric tube 2.
  • tubular net 2 can be seen to be again formed of a single metal wire zigzag bent so as to form a substantially triangular wave, but in this case loops 3 are obtained by bending outwards, with the shape of a triangle, a portion of the wire segments included between one crest and one valley.
  • tubular net 2 is arranged inside fabric tube 1 , while loops 3 protrude outwards crossing a multiplicity of through holes made in the tube itself.
  • tubular net 2 is again obtained by zigzag bending a single metal wire so as to form a substantially triangular wave, which is though provided with alternated crests and valleys having the same height.
  • the points of valleys 5 are bent outwards about by half in the direction of crests 4, so that they are arranged as in the dotted lines 10 of figure 12.
  • tubular net 2 is obtained by zigzag bending a single metal wire with alternated crests and valleys having the same heights, as in the fifth embodiment.
  • the endoprosthesis according to the present invention is compressed as in the figure and arranged in a known way into a suitable tubular container 1 1 , which has the function of bringing the endoprosthesis in the desired position. Once in position, the endoprosthesis is taken out from the tubular container, thus being free to expand inside the duct, possibly with the help of a ball catether, and taking the former shape with the loops protruding outwards.
  • crests 4 are fastened to valleys 5 not through microscopic sutures, but by means of weldings with supply of metallic material preferably equal to that of the whole tubular net 2. for example the same nitinol.
  • embodiments of the present invention can comprise more than one biocompatible fabric tubes and/or tubular nets, for instance a external tubular net for anchorage and an internal tubular net supporting the fabric tube.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne une prothèse endovasculaire tubulaire généralement désignée par l'appellation anglaise «stent», cette prothèse comprenant au moins un tube (1) fabriqué dans un tissu biocompatible intégré à au moins un filet tubulaire (2) présentant sensiblement le même diamètre, certaines parties des mailles de ce filet tubulaire (2) étant pliées de manière à former une multiplicité de boucles (3), lesquelles font saillie à l'extérieur du tube (1) de tissu biocompatible. La présente invention concerne également l'utilisation de cette prothèse endovasculaire.
PCT/IT2000/000032 1999-02-05 2000-02-03 Prothese endovasculaire tubulaire uretrale, biliaire, ou oesophagienne Ceased WO2000045737A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP00905261A EP1158932A1 (fr) 1999-02-05 2000-02-03 Prothese endovasculaire tubulaire uretrale, biliaire, ou oesophagienne
AU26884/00A AU2688400A (en) 1999-02-05 2000-02-03 Urethral, biliary or esophagal tubular endoprosthesis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI99A000236 1999-02-05
IT1999MI000236 IT1307765B1 (it) 1999-02-05 1999-02-05 Endoprotesi tubolare, in particolare per l'uso nei dotti ureterali ebiliari, nonche' nell'esofago.

Publications (1)

Publication Number Publication Date
WO2000045737A1 true WO2000045737A1 (fr) 2000-08-10

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT2000/000032 Ceased WO2000045737A1 (fr) 1999-02-05 2000-02-03 Prothese endovasculaire tubulaire uretrale, biliaire, ou oesophagienne

Country Status (4)

Country Link
EP (1) EP1158932A1 (fr)
AU (1) AU2688400A (fr)
IT (1) IT1307765B1 (fr)
WO (1) WO2000045737A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005112821A3 (fr) * 2004-05-20 2006-04-27 Med Inst Inc Fixation biologique amelioree de greffes
EP1429687A4 (fr) * 2001-09-04 2008-03-12 Graeme Cocks Stent
EP2316392A1 (fr) * 2009-10-27 2011-05-04 Taewoong Medical Co., Ltd. Endoprothèse pour l'extension de l'urètre prostatique
EP2572674A3 (fr) * 2001-07-06 2013-08-07 Syntach AG Dispositif régulateur de pression sanguine implantable
CN105559952A (zh) * 2014-10-21 2016-05-11 太雄医疗器株式会社 制造抗偏移支架的方法及通过该方法制成的支架
CN110251283A (zh) * 2013-03-15 2019-09-20 波士顿科学国际有限公司 抗迁移支架涂层
WO2020160008A1 (fr) 2019-01-28 2020-08-06 Spiros Manolidis Stent et pose de stent pour chirurgie vasculaire
US11666464B2 (en) 2019-01-28 2023-06-06 Tensor Flow Ventures Llc Magnetic stent and stent delivery
US12257165B2 (en) 2021-07-26 2025-03-25 Tensor Flow Ventures Llc Dual stent and delivery system, delivery tool apparatus, and method of delivery of dual stents
US12279983B2 (en) 2021-07-26 2025-04-22 Tensor Flow Ventures Llc Dual stent and delivery system, delivery tool apparatus, and method of delivery of dual stents

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0732088A2 (fr) * 1995-03-14 1996-09-18 Advanced Cardiovascular Systems, Inc. Stent expansible formant des griffes d'ancrage et méthode de déploiement
US5575818A (en) * 1995-02-14 1996-11-19 Corvita Corporation Endovascular stent with locking ring
WO1998019631A1 (fr) * 1996-11-07 1998-05-14 Vascular Science Inc. Appareil et procedes de greffe chirurgicale artificielle

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5575818A (en) * 1995-02-14 1996-11-19 Corvita Corporation Endovascular stent with locking ring
EP0732088A2 (fr) * 1995-03-14 1996-09-18 Advanced Cardiovascular Systems, Inc. Stent expansible formant des griffes d'ancrage et méthode de déploiement
WO1998019631A1 (fr) * 1996-11-07 1998-05-14 Vascular Science Inc. Appareil et procedes de greffe chirurgicale artificielle

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2572674A3 (fr) * 2001-07-06 2013-08-07 Syntach AG Dispositif régulateur de pression sanguine implantable
EP1429687A4 (fr) * 2001-09-04 2008-03-12 Graeme Cocks Stent
WO2005112821A3 (fr) * 2004-05-20 2006-04-27 Med Inst Inc Fixation biologique amelioree de greffes
AU2005244993B2 (en) * 2004-05-20 2011-03-31 Cook Medical Technologies Llc Enhanced biological fixation of grafts
EP2316392A1 (fr) * 2009-10-27 2011-05-04 Taewoong Medical Co., Ltd. Endoprothèse pour l'extension de l'urètre prostatique
CN110251283A (zh) * 2013-03-15 2019-09-20 波士顿科学国际有限公司 抗迁移支架涂层
EP3042638A1 (fr) * 2014-10-21 2016-07-13 Taewoong Medical Co., Ltd. Procédé de fabrication d'un extenseur anti-migration et extenseur ainsi fabriqué
CN105559952B (zh) * 2014-10-21 2017-11-21 太雄医疗器株式会社 抗偏移支架
CN105559952A (zh) * 2014-10-21 2016-05-11 太雄医疗器株式会社 制造抗偏移支架的方法及通过该方法制成的支架
WO2020160008A1 (fr) 2019-01-28 2020-08-06 Spiros Manolidis Stent et pose de stent pour chirurgie vasculaire
EP3917460A4 (fr) * 2019-01-28 2022-11-09 Tensor Flow Ventures LLC Stent et pose de stent pour chirurgie vasculaire
US11666464B2 (en) 2019-01-28 2023-06-06 Tensor Flow Ventures Llc Magnetic stent and stent delivery
US11998467B2 (en) 2019-01-28 2024-06-04 Tensor Flow Ventures Llc Stent delivery for vascular surgery
US12161573B2 (en) 2019-01-28 2024-12-10 Tensor Flow Ventures Llc Stent and stent delivery for vascular surgery
US12257165B2 (en) 2021-07-26 2025-03-25 Tensor Flow Ventures Llc Dual stent and delivery system, delivery tool apparatus, and method of delivery of dual stents
US12279983B2 (en) 2021-07-26 2025-04-22 Tensor Flow Ventures Llc Dual stent and delivery system, delivery tool apparatus, and method of delivery of dual stents

Also Published As

Publication number Publication date
AU2688400A (en) 2000-08-25
ITMI990236A1 (it) 2000-08-05
EP1158932A1 (fr) 2001-12-05
IT1307765B1 (it) 2001-11-19

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